NCT07668336RecruitingPhase 3
A Study of Orforglipron (LY3502970) Compared With Dulaglutide in Pediatric Participants With Type 2 Diabetes
A Phase 3, Randomized, Open-Label Study to Investigate the Efficacy, Safety, and Pharmacokinetics of Once-Daily Oral Orforglipron Compared With Once-Weekly Dulaglutide in Pediatric Participants 10 to Less Than 18 Years of Age With Type 2 Diabetes
Source: ClinicalTrials.gov · Last updated 19 Oct 2026
Brief summary (registry, in English)
This study looks at how well a medicine called orforglipron works compared to another medicine called dulaglutide in pediatric participants aged 10 to less than 18 years with type 2 diabetes. The study will also check how safe these medicines are and how the body processes them. Participation in the study will last about 61 weeks.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 170 (estimated)
- First submitted
- 22 Jun 2026
- Start date
- 8 Jul 2026
- Primary completion date
- 31 Mar 2030
- Lead sponsor
- Eli Lilly and Company
- Diseases
- Type 2 diabetes
- NCT number
- NCT07668336
- EU CT number
- 2025-524811-35-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 170
- From 8 Jul 2026 to the primary completion date, 31 Mar 2030
- 71 sites in 11 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have had at least one episode of severe hypoglycemia and/or at least one episode of hypoglycemic unawareness within the last 6 months before screening
- Have been treated with prescription drugs or over-the-counter medications that promote weight loss within 90 days prior to screening
Other illness
- Have type 1 diabetes
- After the type 2 diabetes diagnosis, have a history of diabetic ketoacidosis or hyperosmolar syndrome
- Have a history of pancreatitis or gallbladder disease
- Have a personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2)
Lab values
- Have received treatment with any glucose-lowering agent(s) other than metformin, basal insulin, or (SGLT2) inhibitors within 90 days prior to screening
Who the study is looking for
- Have type 2 diabetes treated with diet and exercise and metformin and/or basal insulin
- Have HbA1c \> 6.5% to ≤ 11.0% at screening
- Have a body weight ≥50 kilograms (kg) (110 pounds) and a body mass index (BMI) of \>85th percentile
Age in the registry: 10 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (71)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Saint Luc Coordinator of this site? Confirm its status | Brussels | Belgium | Recruiting |
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Gent | Belgium | Recruiting |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| Instituto de Pesquisa Clínica de Campinas Coordinator of this site? Confirm its status | Campinas | Brazil | Not yet recruiting |
| Centro de Pesquisa Sao Lucas Coordinator of this site? Confirm its status | Campinas | Brazil | Not yet recruiting |
| Cendi - Endocrinologia e Diabetes Coordinator of this site? Confirm its status | Goiânia | Brazil | Not yet recruiting |
| Instituto Mederi de Pesquisa e Saude Coordinator of this site? Confirm its status | Passo Fundo | Brazil | Not yet recruiting |
| Instituto da Crianca com Diabetes Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Not yet recruiting |
| IBTED - Tecnologia e Educação em Diabetes Coordinator of this site? Confirm its status | São Paulo | Brazil | Not yet recruiting |
| Instituto de Pesquisa Clinica Coordinator of this site? Confirm its status | São Paulo | Brazil | Not yet recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario Regional de Málaga Coordinator of this site? Confirm its status | Málaga | Spain | Recruiting |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Recruiting |
| Hull Royal Infirmary Coordinator of this site? Confirm its status | Hull | United Kingdom | Not yet recruiting |
| Alder Hey Children's Hospital Coordinator of this site? Confirm its status | Liverpool | United Kingdom | Not yet recruiting |
| Royal London Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Not yet recruiting |
| Avron Hospitals Coordinator of this site? Confirm its status | Ahmedabad | India | Not yet recruiting |
| Gujarat Endocrin Pvt Ltd Coordinator of this site? Confirm its status | Ahmedabad | India | Not yet recruiting |
| Jawaharlal Nehru Medical College Coordinator of this site? Confirm its status | Aligarh | India | Not yet recruiting |
| All India Institute of Medical Sciences Coordinator of this site? Confirm its status | Bhubaneswar | India | Not yet recruiting |
| Endolife Speciality Hospitals Coordinator of this site? Confirm its status | Guntur | India | Not yet recruiting |
| King Edward Memorial Hospital & Seth Gordhandas Sunderdas Medical College Coordinator of this site? Confirm its status | Mumbai | India | Not yet recruiting |
| Harmony Health Hub Coordinator of this site? Confirm its status | Nashik | India | Not yet recruiting |
| All India Institute of Medical Sciences Coordinator of this site? Confirm its status | New Delhi | India | Not yet recruiting |
| Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G Salesi Coordinator of this site? Confirm its status | Ancona | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Meyer IRCCS Coordinator of this site? Confirm its status | Florence | Italy | Recruiting |
| IRCCS Istituto Giannina Gaslini Coordinator of this site? Confirm its status | Genoa | Italy | Recruiting |
| Università degli Studi di Messina Coordinator of this site? Confirm its status | Messina | Italy | Recruiting |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Federico II Di Napoli Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Integrata Verona Coordinator of this site? Confirm its status | Verona | Italy | Recruiting |
| Nihon University Hospital Coordinator of this site? Confirm its status | Chiyoda-ku | Japan | Not yet recruiting |
| Fukuoka Children's Hospital Coordinator of this site? Confirm its status | Fukuoka | Japan | Recruiting |
| Saitama Medical University Hospital Coordinator of this site? Confirm its status | Iruma | Japan | Not yet recruiting |
| Shiga General Hospital Coordinator of this site? Confirm its status | Moriyama | Japan | Recruiting |
| Niigata University Medical & Dental Hospital Coordinator of this site? Confirm its status | Niigata | Japan | Recruiting |
| Osaka City General Hospital Coordinator of this site? Confirm its status | Osaka | Japan | Recruiting |
| Saitama City Hospital Coordinator of this site? Confirm its status | Saitama | Japan | Recruiting |
| Sendai City Hospital - Asutonagamachi Coordinator of this site? Confirm its status | Sendai | Japan | Recruiting |
| Shizuoka Children's Hospital Coordinator of this site? Confirm its status | Shizuoka | Japan | Recruiting |
| Urakami Pediatric Endocrinology and Diabetes Clinic Coordinator of this site? Confirm its status | Tokyo | Japan | Recruiting |
| Juntendo University Urayasu Hospital Coordinator of this site? Confirm its status | Urayasu | Japan | Not yet recruiting |
| Soon Chun Hyang University Bucheon Hospital Coordinator of this site? Confirm its status | Bucheon-si | South Korea | Not yet recruiting |
| Kyungpook National University Chilgok Hospital Coordinator of this site? Confirm its status | Deagu | South Korea | Not yet recruiting |
| Chungnam national university hospital Coordinator of this site? Confirm its status | Junggu | South Korea | Not yet recruiting |
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | Seongnam | South Korea | Not yet recruiting |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Not yet recruiting |
| Centro de Estudios de Investigacion Metabolicos y Cardiovasculares, S.C. Coordinator of this site? Confirm its status | Ciudad Madero | Mexico | Not yet recruiting |
| Centro de Investigacion Medica de Occidente, S.C. Coordinator of this site? Confirm its status | Guadalajara | Mexico | Not yet recruiting |
| Clínica García Flores SC Coordinator of this site? Confirm its status | Monterrey | Mexico | Not yet recruiting |
| UBAM Unidad Biomedica Avanzada Monterrey Coordinator of this site? Confirm its status | Monterrey | Mexico | Not yet recruiting |
| Centro de investigación y control metabólico Coordinator of this site? Confirm its status | Monterrey | Mexico | Not yet recruiting |
| China Medical University Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Not yet recruiting |
| Chang Gung Medical Foundation-Linkou Branch Coordinator of this site? Confirm its status | Taoyuan | Taiwan | Not yet recruiting |
| Medical Research Partners Coordinator of this site? Confirm its status | Ammon | United States | Recruiting |
| Children's Healthcare of Atlanta - Center for Advanced Pediatrics (CAP) Coordinator of this site? Confirm its status | Atlanta | United States | Not yet recruiting |
| Gadolin Research Coordinator of this site? Confirm its status | Beaumont | United States | Recruiting |
| Driscoll Children's Hospital Coordinator of this site? Confirm its status | Corpus Christi | United States | Recruiting |
| CenExel iResearch, LLC Coordinator of this site? Confirm its status | Decatur | United States | Recruiting |
| Proactive Clinical Research LLC Coordinator of this site? Confirm its status | Edinburg | United States | Recruiting |
| Vanderbilt Health One Hundred Oaks Coordinator of this site? Confirm its status | Nashville | United States | Not yet recruiting |
| Sutter Valley Medical Foundation (SVMF) Pediatric Endocrinology Coordinator of this site? Confirm its status | Sacramento | United States | Not yet recruiting |
| Rady Children's Hospital Coordinator of this site? Confirm its status | San Diego | United States | Not yet recruiting |
| Consano Clinical Research, LLC Coordinator of this site? Confirm its status | Shavano Park | United States | Recruiting |
| Frontier Clinical Research, LLC Coordinator of this site? Confirm its status | Smithfield | United States | Recruiting |
| Stamford Therapeutics Consortium Coordinator of this site? Confirm its status | Stamford | United States | Recruiting |
| SUNY Upstate Medical University Coordinator of this site? Confirm its status | Syracuse | United States | Not yet recruiting |
| Advantage Clinical Trials Coordinator of this site? Confirm its status | The Bronx | United States | Recruiting |
| Cotton O'Neil Diabetes & Endocrinology Coordinator of this site? Confirm its status | Topeka | United States | Recruiting |
| Central States Research Coordinator of this site? Confirm its status | Tulsa | United States | Recruiting |
| Victoria Clinical Research Group Coordinator of this site? Confirm its status | Victoria | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.